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510(k) Data Aggregation

    K Number
    K101621
    Device Name
    LITE ART
    Manufacturer
    SHOFU DENTAL CORP.
    Date Cleared
    2010-08-23

    (75 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LITE ART

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    LITE ART is dental resin-based stain material intended to harmonize the color of polymer-based C&B composite resin restorations with surrounding natural dentition. Specific usage of this product is as follows: 1) To characterize and modify C&B composite resin or acrylic resin restorations and 2) To characterize and modify hard resin teeth and acrylic resin teeth.

    Device Description

    Not Found

    AI/ML Overview

    This letter is a 510(k) clearance for a dental resin material named "Lite Art." It confirms that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain the acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot extract the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on performance studies with specific acceptance criteria.

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